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2016 ; 6
(10
): e012594
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Non-inferiority trials: are they inferior? A systematic review of reporting in
major medical journals
#MMPMID27855102
Rehal S
; Morris TP
; Fielding K
; Carpenter JR
; Phillips PP
BMJ Open
2016[Oct]; 6
(10
): e012594
PMID27855102
show ga
OBJECTIVE: To assess the adequacy of reporting of non-inferiority trials
alongside the consistency and utility of current recommended analyses and
guidelines. DESIGN: Review of randomised clinical trials that used a
non-inferiority design published between January 2010 and May 2015 in medical
journals that had an impact factor >10 (JAMA Internal Medicine, Archives Internal
Medicine, PLOS Medicine, Annals of Internal Medicine, BMJ, JAMA, Lancet and New
England Journal of Medicine). DATA SOURCES: Ovid (MEDLINE). METHODS: We searched
for non-inferiority trials and assessed the following: choice of non-inferiority
margin and justification of margin; power and significance level for sample size;
patient population used and how this was defined; any missing data methods used
and assumptions declared and any sensitivity analyses used. RESULTS: A total of
168 trial publications were included. Most trials concluded non-inferiority (132;
79%). The non-inferiority margin was reported for 98% (164), but less than half
reported any justification for the margin (77; 46%). While most chose two
different analyses (91; 54%) the most common being intention-to-treat (ITT) or
modified ITT and per-protocol, a large number of articles only chose to conduct
and report one analysis (65; 39%), most commonly the ITT analysis. There was lack
of clarity or inconsistency between the type I error rate and corresponding CIs
for 73 (43%) articles. Missing data were rarely considered with (99; 59%) not
declaring whether imputation techniques were used. CONCLUSIONS: Reporting and
conduct of non-inferiority trials is inconsistent and does not follow the
recommendations in available statistical guidelines, which are not wholly
consistent themselves. Authors should clearly describe the methods used and
provide clear descriptions of and justifications for their design and primary
analysis. Failure to do this risks misleading conclusions being drawn, with
consequent effects on clinical practice.
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